An Open-Label,Expanded Acces Program with Nivolumab(ONO-4538)for cancer of unknown primary(CUP) - NivoCUP-2

akagawa Kazuhiko0 sites60 target enrollmentMarch 4, 2021

Overview

No summary available.

Registry

who.int

Start Date

March 4, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

akagawa Kazuhiko

•1\.Subjects with histologically confirmed cancer of unknown primary site based on adequate investigation of primary sites (excludes subjects who were pathologically diagnosed with malignant melanoma, malignant lymphoma or sarcoma)
•2\.Treatment naive or previously treated
•3\. Men and women above 20\-years of age
•4\. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
•5\. Expected more than 90 days survival
•6\. Have a Evaluable disease(With or without measurable lesions in RECIST 1\.1\)
•7\. SpO2 at room air is higher than 94% by pulse oximeter within 7 days before registration
•8\.Patients whose latest laboratory test values performed within 7 days before enrollment meet the following criteria
•9\.Women of childbearing potential must agree to follow instructions for methods of contraception from the time of enrollment for the duration of treatment with nivolumab plus 5 months post\-treatment completion. Women must not be breastfeeding
•10\.Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines

•1\. Indication for curative surgery or radiotherapy
•2\. Favorable subsets under treatable condition
•3\. Proven primary site before enrollment
•4\. Subjects with an active, chronic or recurrent autoimmune disease
•5\. Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications
•6\. Prior therapy with drug targeting immune\-checkpoint pathways
•7\. History of allergy or hypersensitivity to drug components
•8\. Judged that the adverse events from the previous treatment influence on the study evaluation
•9\. Subjects with untreated symptomatic CNS metastases
•10\. Subjects with interstitial lung disease